Staff Design Assurance Engineer, Sustaining in Mahwah, NJ at Stryker Corporation

Date Posted: 11/7/2019

Job Snapshot

Job Description

Who we want

  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do

As a Staff Design Assurance Engineer you will lead Sustaining Quality Engineering activities in the development of orthopedic products to ensure the highest level of product and process quality. You will also provide guidance to the Sustaining Product Development teams to ensure compliance to the company’s quality system and external standards.

  • Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
  • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
  • Demonstrated ability to read and interpret CAD drawings
  • Demonstrated ability to advocate product excellence and quality
  • Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, Regulatory and Marketing. 
  • Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
  • NC/CAPA experience preferred
  • Computer proficiency with Mini-tab or similar analysis program

What you need

  • Bachelor’s Degree in Engineering; Biomedical, Mechanical or related discipline
  • Minimum 4+ years of experience as a Quality Engineer (QE) in a regulated design environment highly preferred.
  • Highly prefer experience within medical device product development life cycle, including risk management and design/ process verification & validation

Work From Home: Occasional

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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